2024
A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.
Siu L, McQuarrie K, Bidadi B, Liu C, Black C, Wang A, Tao Y, Licitra L, Burtness B, Tahara M, Rischin D, Harrington K, Machiels J. A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden. Journal Of Clinical Oncology 2024, 42: 11116-11116. DOI: 10.1200/jco.2024.42.16_suppl.11116.Peer-Reviewed Original ResearchPatient-reported outcomesChemoradiation therapyLA-HNSCCPain killersTumor locationSymptom burdenSolid foodTime of data cut-offPRO scoresQLQ-C30Baseline patient-reported outcomesLocally advanced headPrimary tumor locationData cut-offBaseline PRO scoresWeight lossPatient-reported outcomes analysisBaseline item scoresAssociated with high symptom burdenInvestigating pembrolizumabPatient-reported outcome dataAdvanced headHigh symptom burdenDouble-blindEvent-free
2023
PS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412
Tahara M, Machiels J, Tao Y, Burtness B, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Swaby R, Zhang Y, Bidadi B, Siu L. PS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412. Annals Of Oncology 2023, 34: s1380. DOI: 10.1016/j.annonc.2023.09.109.Peer-Reviewed Original Research
2022
LBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC)
Machiels J, Tao Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Swaby R, Zhang Y, Gumuscu B, Bidadi B, Siu L. LBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2022, 33: s1399. DOI: 10.1016/j.annonc.2022.08.029.Peer-Reviewed Original Research
2021
Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis
Petit C, Lacas B, Pignon J, Le Q, Grégoire V, Grau C, Hackshaw A, Zackrisson B, Parmar M, Lee J, Ghi M, Sanguineti G, Temam S, Cheugoua-Zanetsie M, O'Sullivan B, Posner M, Vokes E, Hernandez J, Szutkowski Z, Lartigau E, Budach V, Suwiński R, Poulsen M, Kumar S, Laskar S, Mazeron J, Jeremic B, Simes J, Zhong L, Overgaard J, Fortpied C, Torres-Saavedra P, Bourhis J, Aupérin A, Blanchard P, Groups M, Adelstein D, Agarwal J, Alfonsi M, Argiris A, Aupérin A, Bacigalupo A, Bar-Ad V, Bartelink H, Beadle B, Belkacemi Y, Bensadoun R, Bernier J, Blanchard P, Bourhis J, Bratland Å, Brizel D, Budach V, Budach W, Burtness B, Calais G, Campbell B, Caudell J, Chabaud S, Chamorey E, Chaukar D, Cheugoua-Zanetsie M, Cho K, Choussy O, Hernandez J, Denham J, Dobrowsky W, Dominello M, Driessen C, Fallai C, Forastiere A, Fortpied C, Fountzilas G, Garaud P, Garden A, Gery B, Ghadjar P, Ghi M, Laskar S, Graff-Cailleaud P, Grau C, Gregoire V, Hackshaw A, Haddad E, Haffty B, Hansen A, Hay J, Hayoz S, Horiot J, Hitt R, Jeremic B, Johansen J, Jones C, Julieron M, Kristensen C, Kumar S, Lacas B, Langendijk J, Lapeyre M, Lartigau E, Licitra L, Le Q, Lee J, Lee P, Lewin F, Li Y, Lopes A, Lotayef M, Maciejewski B, Mazeron J, Mehta S, Michalski W, Moon J, Moon S, Moyal E, Nankivell M, Nilsson P, Olmi P, Orecchia R, O'Sullivan B, Overgaard J, Parmar M, Petit C, Pignon J, Pointreau Y, Posner M, Poulsen M, Quon H, Racadot S, Rosenthal D, Rovea P, Redda M, Sanguineti G, Shenouda G, Simes J, Sharma A, Simon C, Sire C, Skladowski K, Spencer S, Staar S, Strojan P, Stromberger C, Suwinski R, Szutkowski Z, Takácsi-Nagy Z, Tao Y, Temam S, Thomson D, Tobias J, Torres-Saavedra P, Torri V, Tripcony L, Trotti A, Tseroni V, van Herpen C, van Tinteren H, Vermorken J, Viegas C, Vokes E, Waldron J, Wernecke K, Widder J, Wolf G, Wong S, Wu J, Yamazaki H, Zaktonik B, Zackrisson B, Zhong L. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis. The Lancet Oncology 2021, 22: 727-736. PMID: 33862002, DOI: 10.1016/s1470-2045(21)00076-0.Peer-Reviewed Original ResearchConceptsOverall survivalLocoregional therapyAdvanced headNeck cancerConcomitant chemotherapyConcomitant chemoradiotherapyIndividual patient data networkNeck squamous cell cancerAltered fractionation radiotherapyNon-metastatic headRole of chemotherapyPlatinum-based chemotherapySquamous cell cancerModalities of treatmentLog-rank testIndividual patient dataCochran's Q statisticInstitut National du CancerP scoreInduction chemotherapyFractionation radiotherapyPrimary endpointHazard ratioHyperfractionated radiotherapySurvival benefit
2020
ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer
Cmelak A, Dietrich MS, Li S, Ridner S, Forastiere A, Burtness BA, Cella D, Murphy BA. ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer. Cancers Of The Head & Neck 2020, 5: 12. PMID: 33353553, PMCID: PMC7756946, DOI: 10.1186/s41199-020-00059-1.Peer-Reviewed Original ResearchQuality of lifeFunctional communication measuresMajority of patientsVoice Handicap IndexFACT-HNSwallow assessmentEffects of chemoradiationLarge therapeutic trialsPatient related outcomesSevere dysphagiaAdvanced headOverall survivalBarium swallowTherapeutic trialsNeck cancerSwallow functionSurrogate markerDisability AssessmentLarynx cancerFunctional assessmentPatientsHandicap IndexVocal functionRelated outcomesMarked decreasePredictive classifier for intensive treatment of head and neck cancer
Zakeri K, Rotolo F, Lacas B, Vitzthum LK, Le Q, Gregoire V, Overgaard J, Hackshaw A, Zackrisson B, Parmar MKB, Burtness BA, Ghi MG, Sanguineti G, O’Sullivan B, Fortpied C, Bourhis J, Shen H, Harris J, Michiels S, Pignon J, Mell LK, Intergroup F. Predictive classifier for intensive treatment of head and neck cancer. Cancer 2020, 126: 5263-5273. PMID: 33017867, DOI: 10.1002/cncr.33212.Peer-Reviewed Original ResearchConceptsOverall survivalIntensive treatmentΩ scoreNeck cancerGood performance statusEffect of chemotherapyOral cavity sitesPerformance statusAdvanced headRandomized trialsControl armHigh riskN categoryPatientsRelative hazardYounger ageEvent riskEvent regressionCancerCancer progressionUnknown statusTreatment effectsChemotherapyScoresTreatmentPembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412
Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Lima I, Pointreau Y, Hughes B, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncology 2020, 16: 1235-1243. PMID: 32490686, DOI: 10.2217/fon-2020-0184.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaPhase III trialsSquamous cell carcinomaChemoradiation therapyAdvanced headIII trialsCell carcinomaImmune checkpoint inhibitor pembrolizumabLarge phase III trialsCheckpoint inhibitor pembrolizumabUse of pembrolizumabCurrent treatment guidelinesAdvanced HNSCCAdvanced diseaseMaintenance therapyMetastatic HNSCCTreatment guidelinesMaintenance treatmentMultimodal treatmentPembrolizumabPatientsAntitumor activityIB dataChemoradiationHNSCC
2019
Radiation therapy treatment facility and overall survival in the adjuvant setting for locally advanced head and neck squamous cell carcinoma
Lee NCJ, Kelly JR, An Y, Park HS, Judson BL, Burtness BA, Husain ZA. Radiation therapy treatment facility and overall survival in the adjuvant setting for locally advanced head and neck squamous cell carcinoma. Cancer 2019, 125: 2018-2026. PMID: 30748002, PMCID: PMC6541535, DOI: 10.1002/cncr.32001.Peer-Reviewed Original ResearchConceptsHigh-volume surgical facilitiesPostoperative radiation therapyNeck squamous cell carcinomaSquamous cell carcinomaOverall survivalSurvival benefitCell carcinomaSurgical facilitiesPropensity score-matched cohortAnnual case volumeDefinitive surgeryAdvanced headOS improvementImproved outcomesRadiation therapyCase volumeOral cavityPatientsReduced hazardMultivariate analysisSurgeryInvasive HNSCCCarcinomaSurvivalTreatment
2018
1121TiP KEYNOTE-412: Phase III study of pembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma (HNSCC)
Machiels J, Licitra L, Tao Y, Yen C, Rischin D, Waldron J, Burtness B, Gregoire V, Agarwala S, Yorio J, Delord J, Aksoy S, Ikeda S, Hong R, Ge J, Brown H, Bidadi B, Siu L. 1121TiP KEYNOTE-412: Phase III study of pembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2018, 29: viii398. DOI: 10.1093/annonc/mdy287.078.Peer-Reviewed Original ResearchEfficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012
Mehra R, Seiwert TY, Gupta S, Weiss J, Gluck I, Eder JP, Burtness B, Tahara M, Keam B, Kang H, Muro K, Geva R, Chung HC, Lin CC, Aurora-Garg D, Ray A, Pathiraja K, Cheng J, Chow LQM, Haddad R. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012. British Journal Of Cancer 2018, 119: 153-159. PMID: 29955135, PMCID: PMC6048158, DOI: 10.1038/s41416-018-0131-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedB7-H1 AntigenDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckConceptsTreatment-related adverse eventsNeck squamous cell carcinomaSquamous cell carcinomaAdverse eventsCell carcinomaDurable anti-tumor activityRecurrent/metastatic headRecurrent/metastatic HNSCCEfficacy of pembrolizumabSafety of pembrolizumabTolerable safety profileUse of pembrolizumabMedian response durationNon-randomised trialsOverall response rateCo-primary endpointsTreatment of HNSCCYears of treatmentAnti-tumor activityConclusionsSome patientsKEYNOTE-012MethodsMulti-centreGrade 3/4Metastatic headAdvanced headPembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma: The phase 3 KEYNOTE-412 study.
Machiels J, Licitra L, Tao Y, Yen C, Rischin D, Waldron J, Burtness B, Gregoire V, Agarwala S, Yorio J, Delord J, Aksoy S, Ikeda S, Hong R, Ge J, Brown H, Bidadi B, Siu L. Pembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma: The phase 3 KEYNOTE-412 study. Journal Of Clinical Oncology 2018, 36: tps6094-tps6094. DOI: 10.1200/jco.2018.36.15_suppl.tps6094.Peer-Reviewed Original Research
2017
96TiP Phase 3 KEYNOTE-412 trial: Pembrolizumab plus chemoradiation (CRT) vs CRT alone for locally advanced head and neck squamous cell carcinoma (LA-HNSCC)
Machiels J, Yen C, Licitra L, Rischin D, Waldron J, Burtness B, Gregoire V, Tao Y, Yorio J, Aksoy S, Ikeda S, Hong R, Ge J, Brown H, Bidadi B, Siu L. 96TiP Phase 3 KEYNOTE-412 trial: Pembrolizumab plus chemoradiation (CRT) vs CRT alone for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Annals Of Oncology 2017, 28: xi28. DOI: 10.1093/annonc/mdx711.077.Peer-Reviewed Original Research373TiP KEYNOTE-412: Phase 3 trial of pembrolizumab plus chemoradiation (CRT) vs CRT alone for locally advanced head and neck squamous cell carcinoma (LA-HNSCC)
Yen C, Machiels J, Licitra L, Rischin D, Waldron J, Burtness B, Gregoire V, Tao Y, Yorio J, Aksoy S, Ikeda S, Hong R, Ge J, Brown H, Bidadi B, Siu L. 373TiP KEYNOTE-412: Phase 3 trial of pembrolizumab plus chemoradiation (CRT) vs CRT alone for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Annals Of Oncology 2017, 28: x110. DOI: 10.1093/annonc/mdx665.036.Peer-Reviewed Original Research1105TiP Pembrolizumab plus chemoradiation (CRT) for the treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Phase 3 KEYNOTE-412 trial
Machiels J, Licitra L, Rischin D, Waldron J, Burtness B, Grégoire V, Shekar T, Brown H, Cheng J, Siu L. 1105TiP Pembrolizumab plus chemoradiation (CRT) for the treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Phase 3 KEYNOTE-412 trial. Annals Of Oncology 2017, 28: v392. DOI: 10.1093/annonc/mdx374.056.Peer-Reviewed Original ResearchKEYNOTE-412: Pembrolizumab (pembro) in combination with chemoradiation versus chemoradiation alone in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Machiels J, Licitra L, Rischin D, Waldron J, Burtness B, Gregoire V, Shekar T, Brown H, Cheng J, Siu L. KEYNOTE-412: Pembrolizumab (pembro) in combination with chemoradiation versus chemoradiation alone in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Journal Of Clinical Oncology 2017, 35: tps6090-tps6090. DOI: 10.1200/jco.2017.35.15_suppl.tps6090.Peer-Reviewed Original ResearchBlinded independent central reviewConcomitant chemoradiotherapyRECIST v1.1LA-HNSCCP16-positive oropharyngeal cancerPrimary efficacy end pointRecurrent/metastatic HNSCCNeck squamous cell carcinomaDefinitive concomitant chemoradiotherapyECOG PS 0Efficacy end pointOutcome of ptsP16 negative HNSCCEvent-free survivalHalf of patientsSquamous cell carcinomaEnd of treatmentIndependent central reviewQuality of lifeMeasurable diseaseAdvanced diseaseCTCAE v4.0Primary surgeryAdvanced headNeck dissection
2014
Projections: Novel Therapies for HPV-Negative Cancers of the Head and Neck
Burtness B. Projections: Novel Therapies for HPV-Negative Cancers of the Head and Neck. Current Cancer Research 2014, 343-359. DOI: 10.1007/978-1-4614-8815-6_17.Peer-Reviewed Original ResearchHuman papillomavirusNeck cancerNovel therapiesHPV-negative cancersPD-1 inhibitorsIntensification of therapyHPV-negative headReceptor c-MetAdvanced headImmune suppressionCTLA-4Larynx cancerC-MetCurrent trialCancerTherapyMolecular targetsErbB/Radiation techniquesFamily membersBiomolecular profileHeadPatientsPapillomavirusNeck
2012
59IN Strategies to Optimize EGFR Therapies
Burtness B. 59IN Strategies to Optimize EGFR Therapies. Annals Of Oncology 2012, 23: ix42. DOI: 10.1016/s0923-7534(20)32673-9.Peer-Reviewed Original ResearchRecurrent/metastatic diseaseCombination of cetuximabCetuximab resistanceKinase inhibitorsMetastatic diseaseNeck cancerNuclear translocationInternational phase III trialReceptor tyrosine kinasesPhase III trialsSquamous cell carcinomaAugmentation of responsesDe novo resistanceH-ras mutationsMonoclonal antibody cetuximabTyrosine kinase inhibitorsK-ras mutationsFirst kinase inhibitorEpidermal growth factor receptorBristol-Myers SquibbGrowth factor receptorAdvanced headEGFR/HER2III trialsOral agents
2010
Tumor molecular correlates of unresectable, locally advanced head and neck squamous cell carcinoma (SCCHN) response to concurrent radiation (RT), cisplatin (DDP), and cetuximab (C225) in a phase II trial (ECOG 3303).
Egloff A, Lee J, Vaezi A, Langer C, Forastiere A, Quon H, Burtness B, Grandis J. Tumor molecular correlates of unresectable, locally advanced head and neck squamous cell carcinoma (SCCHN) response to concurrent radiation (RT), cisplatin (DDP), and cetuximab (C225) in a phase II trial (ECOG 3303). Journal Of Clinical Oncology 2010, 28: 5537-5537. DOI: 10.1200/jco.2010.28.15_suppl.5537.Peer-Reviewed Original Research
2004
Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up
Psyrri A, Kwong M, DiStasio S, Lekakis L, Kassar M, Sasaki C, Wilson LD, Haffty BG, Son YH, Ross DA, Weinberger PM, Chung GG, Zelterman D, Burtness BA, Cooper DL. Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up. Journal Of Clinical Oncology 2004, 22: 3061-3069. PMID: 15284256, DOI: 10.1200/jco.2004.01.108.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrachytherapyCarcinoma, Squamous CellCisplatinCombined Modality TherapyDrug Administration ScheduleFemaleFluorouracilFollow-Up StudiesHead and Neck NeoplasmsHumansLeucovorinMaleMiddle AgedQuality of LifeRemission InductionSurvival RateTreatment OutcomeConceptsConcurrent cisplatin chemoradiotherapyComplete response rateInduction chemotherapyCisplatin chemoradiotherapyOrgan preservationResponse rateAdvanced headGrade 3Survival rateProgression-free survival ratesNeck squamous cell carcinomaCommon grade 3Courses of cisplatinPartial response ratePhase II studyOverall survival ratePoor functional outcomeSquamous cell carcinomaExternal beam radiotherapyExcellent PFSResectable HNSCCAdvanced diseaseConcurrent chemoradiotherapyPersistent dysphagiaII study